120 Participants Needed

Cardiac Imaging to Predict Embolic Stroke

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NM
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Overseen ByQuintrele Jones, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Tulane University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Demonstrating the pathophysiological link between Left Atrial (LA) and Left Atrial Appendage (LAA) pathology and embolic strokes in non-Atrial Fibrillation (AF) individuals represents a major advance in stroke prevention strategies. Instead of relying on non-specific criteria for stroke risk assessment, the investigators propose to identify individuals with high-risk of embolic stroke using imaging criteria that reflect the underlying pathophysiology of embolic stroke of cardiac origin. the investigators can therefore lay the groundwork for future anticoagulation strategies for stroke prevention beyond AF.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cardiac and Brain MRI in predicting embolic stroke?

Cardiac MRI is highly effective in assessing heart function and structure, which can help identify heart-related issues that might lead to strokes. It provides detailed images of the heart and blood vessels, helping doctors understand conditions like heart disease and blood flow problems that could contribute to stroke risk.12345

Is cardiac and brain MRI safe for humans?

Cardiac and brain MRI is generally considered safe for humans as it is a non-invasive imaging technique that does not use ionizing radiation. However, safety depends on individual factors like the presence of metal implants or devices, which may require special precautions.16789

How is the treatment 'Cardiac and Brain MRI' unique for predicting embolic stroke?

Cardiac and Brain MRI is unique because it provides a non-invasive, three-dimensional view of both the heart and brain, allowing for detailed assessment of cardiovascular and neurological structures without exposure to radiation. This comprehensive imaging approach can help identify potential sources of embolic stroke by evaluating heart function and detecting abnormalities that other imaging techniques might miss.3461011

Research Team

Nassir F. Marrouche, MD | Tulane School ...

Nassir Marrouche, MD

Principal Investigator

Tulane School of Medicine

Eligibility Criteria

This trial is for adults over 18 without atrial fibrillation but with a high stroke risk score (CHA2DS2VASC ≥3), type II diabetes, or history of heart failure/TIA/stroke from unknown causes. It excludes those who've had recent strokes, are allergic to MRI contrast agents, have certain implants, severe kidney disease, weigh over 300 lbs, or are pregnant/breastfeeding.

Inclusion Criteria

You have a CHA2DS2VASC score of 3 or higher.
I have never had atrial fibrillation.
I have a history of heart failure or stroke with no clear cause.
See 2 more

Exclusion Criteria

You cannot have an MRI scan due to a previous allergic reaction to gadolinium, or if you have a pacemaker, defibrillator, or other devices that are not safe for MRI.
My kidney function is low, with an eGFR under 30 ml/min.
You weigh more than 300 pounds, which could affect the quality of the CMR images.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo Cardiac Magnetic Resonance imaging (CMR) and brain MRI to assess for markers of LA and LAA pathology and embolic-appearing brain infarcts

1 day
1 visit (in-person)

Data Analysis

Analysis of cardiac imaging features and their association with embolic-appearing strokes on brain MRI

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after imaging assessment

4 weeks

Treatment Details

Interventions

  • Cardiac and Brain MRI
Trial OverviewThe study tests if advanced cardiac and brain MRI imaging can predict the risk of embolic strokes in people without atrial fibrillation by identifying specific heart abnormalities that could lead to such strokes.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patient armExperimental Treatment1 Intervention
All patients will undergo a CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA. High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI

Cardiac and Brain MRI is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Cardiac and Brain MRI for:
  • Diagnostic imaging for cardiovascular diseases
  • Stroke risk assessment
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Approved in United States as Cardiac and Brain MRI for:
  • Diagnostic imaging for cardiovascular diseases
  • Stroke risk assessment
  • Neurological disorders
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Approved in Canada as Cardiac and Brain MRI for:
  • Diagnostic imaging for cardiovascular diseases
  • Stroke risk assessment
🇯🇵
Approved in Japan as Cardiac and Brain MRI for:
  • Diagnostic imaging for cardiovascular diseases
  • Stroke risk assessment

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials
129
Recruited
259,000+

Findings from Research

Cardiovascular magnetic resonance (CMR) is becoming essential in cardiology, providing precise assessments of heart function and structure, particularly for conditions like ischemic heart disease and heart failure.
The growing accessibility and expertise in CMR outside specialized centers enhance patient care by allowing for detailed evaluations, including unique assessments like myocardial iron overload.
Cardiovascular Magnetic Resonance in Cardiology Practice: A Concise Guide to Image Acquisition and Clinical Interpretation.Valbuena-López, S., Hinojar, R., Puntmann, VO.[2017]
Recent advancements in cardiac MR imaging have significantly improved the speed and detail of assessments, allowing for broader clinical applications beyond just structural analysis to include functional and perfusion evaluations.
This review highlights the effectiveness of cardiac MR in diagnosing various acquired heart diseases, such as ischemic heart disease and cardiomyopathy, showcasing its role in enhancing patient care.
Cardiac disease in the adult: MR evaluation.Bluemke, DA., Halefoglu, AM.[2004]
Cardiovascular MRI is primarily used to assess major blood vessels, but it is increasingly important for evaluating heart-specific conditions like intracardiac masses and congenital heart disease.
The non-invasive nature of MRI allows for detailed three-dimensional imaging of cardiovascular anatomy, suggesting its future role will expand significantly in diagnosing and investigating heart-related pathologies.
Magnetic resonance imaging of cardiac and pericardial disease.Croisille, P., Revel, D.[2016]

References

Cardiovascular Magnetic Resonance in Cardiology Practice: A Concise Guide to Image Acquisition and Clinical Interpretation. [2017]
Cardiac disease in the adult: MR evaluation. [2004]
Magnetic resonance imaging of cardiac and pericardial disease. [2016]
Cardiac magnetic resonance imaging: what can it add clinically in 2004? [2019]
Setting up a clinical cardiac MR imaging program: practical issues and economics. [2019]
[Magnetic resonance imaging: cardiological diagnosis]. [2006]
Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. [2021]
Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. [2016]
Physics and technology of cardiovascular MR imaging. [2019]
MR imaging of the heart: functional imaging. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Valvular heart disease. [2017]